Orange Book product · Brand (NDA)
GADAVIST
GADOBUTROL
Brand (NDA)NDA 201277TE APRX BAYER HLTHCARE
At a glance
Dec 18, 2013
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 18, 2013
12 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
GADOBUTROL
Strength
1.20944GM/2ML (604.72MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 201277
Product number
006
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
